Effect of Reslizumab in Chronic Rhinosinusitis

Phase 3

• Conditions: Sinusitis
• Interventions: Drug: Placebo; Drug: Reslizumab

• Registration Number: NCT02799446
• Lead Sponsor: Joshua S. Jacobs

Brief Summary

The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-14
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Written informed consent
2. Willingness and ability to comply with the requirements of the study
3. Female or male patients ages 18-75 at the time of screening
4. A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery
5. Elevated blood eosinophils
6. Significant findings on computed tomography (CT) scan

Exclusion Criteria

1. Unable to sign informed consent form
2. A woman that is pregnant or nursing a child
3. Known hypersensitivity to Reslizumab
4. Active cigarette smoking in the year prior to screening
5. Known underlying immunodeficiency
6. History of alcohol or drug abuse in the year prior to screening

Other criteria may apply. Please contact the investigator for more information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo.
Reslizumab	Reslizumab	Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.

Primary Outcome Measures

Name	Time	Method
Change in computed tomography (CT) score	24 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life questionnaire	24 weeks
Smell test	24 weeks
Endoscopy score	24 weeks
Adverse events by body system	24 weeks

Trial Locations

Locations (1)

Allergy and Asthma Clinical Research; 🇺🇸 Walnut Creek, California, United States